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Life Sciences Attorneys Co-Author Law360Opinion Article on Bridging Gap Between FDA and Digital Health Industry

Practices: Life Sciences, Digital Health

Life sciences partner Albert Cacozza (Washington, D.C.) co-authored a May 31 Law360 expert opinion article on the need for a cultural exchange to bridge the gap between the digital health industry and the U.S. Food and Drug Administration (FDA).

The co-authors explain that the different backgrounds and expectations between the FDA regulators and the regulated digital health industry can lead to a frustrating and unproductive atmosphere. Collaboration is needed to bring disruptive, innovative, safe and effective medical technology to the market. First, medical device reviewers and policymakers at FDA must truly understand the science and clinical implications of digital health. Second, digital health developers, such as software engineers and code writers, must learn the FDA regulatory landscape.

A model already exists for such a cultural exchange. The National Science Foundation (NSF) has an extensive “rotator” program to attract leading external researchers for temporary government service to augment and complement the agency’s permanent staff. These “rotators,” who are leading scientists, engineers and educators, generally serve one to two years, and provide an infusion of new ideas to keep the NSF informed of cutting-edge developments in America’s science and engineering facilities.

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